Skip to main content
No items found.
Product
Use Cases
Capabilities
Function
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications.
Read more
Solutions
Capabilities
Function
AI/ML in Medical Devices
Rapidly accelerate AI/ML software development and deployment, while staying compliant.
SaMD and Connected Devices
Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.
Jira for 62304
Transform Jira into a validated, compliant platform for medical device development.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Watch a short recorded demo
Traceability
Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.
Documentation
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Enforcement
Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.
SBOM
See a single consolidated view of your open-source supply chain directly from your source code.
Integrations
Integrate Ketryx with your preferred DevTools to automatically establish traceability, create documentation, and enforce your QMS.
Requirements Management
Manage and trace requirements across connected systems like Jira.
Risk Management
Control and document every risk automatically in a 14971-compliant way.
Watch a short recorded demo
QA / RA
Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.
Dev / R&D
Keep your developers working in their preferred DevTools while maintaining compliance and traceability.
Watch a short recorded demo
What is Ketryx?
Connected Lifecycle Management platform for regulated medical applications.
Read more
Use Cases
AI/ML in Medical Devices
Rapidly accelerate AI/ML software development and deployment, while staying compliant.
SaMD and Connected Devices
Reduce the complexity, time, and cost of building SaMD (Software as a Medical Device) applications.
Jira for 62304
Transform Jira into a validated, compliant platform for medical device development.
Traceability to Automated Tests
Automatically trace automated tests in Git to requirements in Jira.
Watch a short recorded demo
Capabilities
Traceability
Automatically create a real-time requirements traceability matrix by connecting items, risks, code, and tests from all your systems.
Documentation
Automatically compile all requirements, design inputs, outputs, and tests into a configurable and submission-ready design history file (DHF).
Enforcement
Enforce your QMS to ensure your team is following SOPs exactly as you've defined them.
SBOM
See a single consolidated view of your open-source supply chain directly from your source code.
Integrations
Integrate Ketryx with your preferred DevTools to automatically establish traceability, create documentation, and enforce your QMS.
Requirements Management
Manage and trace requirements across connected systems like Jira.
Risk Management
Control and document every risk automatically in a 14971-compliant way.
Watch a short recorded demo
Function
QA / RA
Enforce your QMS procedures, prevent process deviation, and ensure your software is audit-ready 100% of the time throughout the SDLC.
Dev / R&D
Keep your developers working in their preferred DevTools while maintaining compliance and traceability.
Watch a short recorded demo
Case Studies
Discover how AI/ML-enabled cardiovascular MedTech company HeartFlow reduced complexity by 90% with a system of systems
See how AI-powered nutrition platform Nutrino reduced SBOM documentation time by 90%
Learn how Beacon Biosignals reduced their release cycle to two weeks for AI/ML products
See how Oui Therapeutics unified and accelerated their software development lifecycle
Explore how Foresight Diagnostics accelerated their documentation cycle by 5x
Pricing
Resources
Documentation
Access Ketryx's extensive product documentation.
Blog
Learn about regulated medical device software development.
Support and FAQs
Customers submit tickets here for all product needs.
Webinars
Hear from experts on medical device software development.
White Papers
Take a deep dive into regulated software development.
About
Company
Learn the origin story of Ketryx and how we got to where we are today.
Why Ketryx
Understand why regulated software teams choose Ketryx.
Careers
Learn about our team and opportunities to join us.
In the News
See recent press about Ketryx's work with life sciences teams.
Certifications
See our compliance with international standards
Get started
Book a demo
Book a Demo
Get Started
Product Announcements
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
Paul Jones
•
April 10, 2024
Filter articles
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Compliance
FDA
Generative AI
News
Product Development
Quality
Regulatory
Risk Management
Traceability
Update
Validation
reset filters
Regulations
Constructive Constraints: Enforcement Is the Key to Faster Medical Software Development
Jan Pöschko
•
August 29, 2024
Product Announcements
Ketryx 2.8
Erez Kaminski
•
August 28, 2024
August 21, 2024
Traceability
Modernizing the Medical Device Factory to Work With Software
Erez Kaminski
•
September 6, 2024
September 4, 2024
FDA
Beyond the Basics: Building FDA-Compliant SBOMs for MedTech
Gabriel Pascualy
•
August 21, 2024
How Connected Lifecycle Management Is Revolutionizing MedTech Software Development
Zack Jha
•
August 7, 2024
August 5, 2024
Can MedTech Use Validated DevOps to Move as Fast as Netflix?
Erez Kaminski
•
July 31, 2024
July 31, 2024
Product Announcements
Ketryx 2.7
Erez Kaminski
•
June 27, 2024
June 3, 2024
FDA Predetermined Change Control Plan (PCCP): Compliance Guide
Lee Chickering
•
August 28, 2024
Product Announcements
Announcing Ketryx’s UL Certification to IEC 62304, ISO 13485, and ISO 14971
Paul Jones
•
June 27, 2024
Ketryx 2.6
Erez Kaminski
•
June 27, 2024
March 29, 2024
FDA
21 CFR Part 11 Compliance Guide for Jira (Atlassian)
Jake Stowe
•
June 27, 2024
Ketryx 2.5
Erez Kaminski
•
June 27, 2024
February 13, 2024
AI/ML
MedTech Trends for 2024: Takeaways from JP Morgan's Health Conference
Erez Kaminski
•
July 3, 2024
January 25, 2024
$14M to Build the Future of Medical Software
Erez Kaminski
•
July 3, 2024
December 5, 2023
Traceability
IEC 62304 & Requirements Traceability Matrix (RTM) in Jira: A Guide for Medical Device Companies
Jan Pöschko
•
July 3, 2024
AI/ML
How to generate an SBOM (Software Bill of Materials) fast
Jan Pöschko
•
June 27, 2024
November 2, 2023
Regulations
Ketryx Guide to RAPS Convergence 2023
Bailey Pearlman
•
July 3, 2024
The latest (June 2023) changes to the FDA’s new premarket submission guidance
Lee Chickering
•
July 3, 2024
October 16, 2023
Regulations
Ketryx’s Guide to DTxEast 2023
Bailey Pearlman
•
July 3, 2024
September 14, 2023
FDA
Simplifying 510K Submissions with FDA’s eSTAR Program and Ketryx
Paul Jones
•
July 3, 2024
September 12, 2023
Best Practices for Maintaining a Requirement Traceability Matrix in Agile
Jake Stowe
•
July 3, 2024
Regulations
PATCH Act: How to Comply in 2023 & Beyond
John Koontz
•
July 3, 2024
August 16, 2023
Traceability
The Best RTM Tools for Agile Teams: Looking Beyond Excel
Jake Stowe
•
July 3, 2024
August 9, 2023
2023 FDA Warning Letters and Software Validation
Erez Kaminski
•
July 3, 2024
August 9, 2023
Regulations
Clinical Trial Computerized Systems Regulation Review
Jake Stowe
•
July 3, 2024
August 9, 2023
Traceability
The Ultimate Guide to Requirements Traceability Matrix (RTM)
Jake Stowe
•
July 3, 2024
June 19, 2023
Traceability
Ketryx 2.0 Release
Erez Kaminski
•
July 3, 2024
May 11, 2023
Regulations
The FDA drops a Cybersecurity Compliance SBOM in 2023
Erez Kaminski
•
July 3, 2024
July 19, 2023
Regulations
The Turtle Problem
Jake Stowe
•
July 3, 2024
April 13, 2023
Regulations
Why the FDA’s Most Common Warning Letter Might Surprise You
Erez Kaminski
•
July 3, 2024
August 24, 2023
Regulations
Key Takeaways from the first Safety-critical Software Meetup in Boston
Erez Kaminski
•
July 3, 2024
April 13, 2023
Traceability
A brief overview of cloud security for standard and safety-critical software
John Koontz
•
July 3, 2024
April 17, 2023
Regulations
Computer Software Assurance
John Koontz
•
July 3, 2024
April 17, 2023
Regulations
SOUP Software Definition and a Guide to Software Regulations of Unknown Provenance
Erez Kaminski
•
July 3, 2024
May 12, 2023
AI/ML
Creating FDA-compliant Medical Devices at Lightning Speed with ChatGPT and Ketryx
Felipe Asfura
•
July 3, 2024
April 13, 2023
Regulations
FDA Traceability Matrix Requirements for Medical Devices
Jake Stowe
•
July 3, 2024
May 26, 2023
Sorry, no results for this filter combination.
Reset filters
.
.svg)
.png)
.png)